Controlled absorption methyldopa pharmaceutical formulation

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules

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424462, 424468, 424473, 424490, 424497, 514965, A61K 950, A61K 958

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active

047160403

ABSTRACT:
A controlled absorption methyldopa formulation for oral administration comprises a pellet having a core of methyldopa or a pharmaceutically acceptable salt thereof in association with an organic acid, and an outer membrane which permits release of methyldopa in an aqueous medium at a controlled rate which is substantially pH independent. The pellet has a dissolution rate in vitro, which when measured in a Basket Assembly according to U.S. Pharmacopoeia XX at 37.degree. C. and 75 r.p.m., is not more than 50% of the total methyldopa after one hour of measurement. Not more than 80% of the total methyldopa is released after a total of 3 hours of measurement and 100% release is achieved after a total of 7 hours.

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